Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

• Status: Withdrawn
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Triamcinolone Acetonide

Criteria

Inclusion criteria:

• Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months

• Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4

• Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

• Hemodialysis CKD Stage 5 Organ transplantation

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

• Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply